Swissmedic

Swissmedic (Swiss Agency for Therapeutic Products) is Switzerland's regulatory authority responsible for ensuring the safety, efficacy, and quality of medical devices, pharmaceuticals, and other therapeutic products marketed in Switzerland. While Switzerland is not part of the European Union, it maintains close regulatory alignment with EU regulations through mutual recognition agreements.

Agency overview:

Full name: Swiss Agency for Therapeutic Products (Swissmedic)
Established: 2002 (consolidating previous regulatory functions)
Legal basis: Therapeutic Products Act (TPA) and Medical Devices Ordinance (MedDO)
Headquarters: Bern, Switzerland
Website: www.swissmedic.ch

Swissmedic responsibilities:
- Market authorization of therapeutic products
- Post-market surveillance and vigilance
- Good Manufacturing Practice (GMP) inspections
- Clinical trial authorization
- Compliance monitoring and enforcement
- International regulatory cooperation

Swiss medical device regulatory framework:

Key legislation:

Therapeutic Products Act (Heilmittelgesetz, HMG/TPA):
Overarching federal law governing all therapeutic products including medical devices.

Medical Devices Ordinance (Medizinprodukteverordnung, MepV/MedDO):
Specific regulations for medical devices, implementing EU MDR and IVDR requirements with Swiss-specific provisions.

Relationship with EU regulations:

Mutual Recognition Agreement (MRA):
Switzerland and the EU historically had a bilateral MRA for medical devices:
- Swiss conformity assessment recognized in EU
- EU conformity assessment recognized in Switzerland
- Facilitated free movement of medical devices between markets

MRA status after EU MDR/IVDR:
The existing MRA does not cover EU MDR 2017/745 or IVDR 2017/746:
- Switzerland updated its regulations to align with MDR/IVDR
- MRA update negotiations ongoing
- Swiss manufacturers may need separate EU certification
- EU manufacturers may need separate Swiss certification
- Situation creates regulatory complexity for both markets

Current approach:
Switzerland recognizes CE marking under MDR/IVDR but has additional Swiss-specific requirements.

Medical device classification:

Switzerland uses the EU MDR/IVDR classification system:

Medical Devices (MDR-aligned):
- Class I - Low risk (e.g., bandages, examination gloves)
- Class IIa - Low-to-moderate risk (e.g., contact lenses, ultrasound)
- Class IIb - Moderate-to-high risk (e.g., ventilators, infusion pumps)
- Class III - High risk (e.g., heart valves, implants)

In Vitro Diagnostics (IVDR-aligned):
- Class A - Lowest risk
- Class B - Low-to-moderate risk
- Class C - Moderate-to-high risk
- Class D - Highest risk

Classification rules follow EU MDR/IVDR Annexes.

Market authorization pathways:

1. CE marking recognition:
Devices with valid CE marking under EU MDR or IVDR are generally recognized in Switzerland, but:
- Must comply with Swiss Medical Devices Ordinance
- Swiss Authorized Representative required
- Registration in Swiss medical device database
- Swiss-specific labeling requirements

2. Swiss conformity assessment:
If no valid CE marking or for Swiss-specific requirements:
- Conformity assessment by Swiss Notified Body
- Technical documentation review
- Quality management system audit (ISO 13485)
- Clinical evaluation assessment
- Swiss certificate issued (equivalent to CE certificate)

Swiss Authorized Representative:

Requirement:
Foreign manufacturers must designate a Swiss Authorized Representative (Swiss AR):
- Legal entity registered in Switzerland
- Authorized to represent manufacturer before Swissmedic
- Maintains technical documentation in Switzerland
- Handles regulatory communications
- Manages post-market surveillance and vigilance
- Similar role to EU Authorized Representative

Swiss AR responsibilities:
- Register devices in Swiss database on behalf of manufacturer
- Ensure labeling compliance with Swiss requirements
- Report adverse events and field safety corrective actions
- Maintain device registration and updates
- Serve as contact for Swissmedic and healthcare professionals

Swiss-specific requirements:

Language requirements:
Switzerland has four official languages (German, French, Italian, Romansh):
- Labeling must include German, French, and Italian at minimum
- Instructions for use in all three languages
- Technical documentation can be in English with summaries in local languages

Swiss registration database:
All medical devices marketed in Switzerland must be registered:
- Device information and classification
- Manufacturer and Swiss AR details
- Conformity assessment certificates
- UDI (Unique Device Identification) data
- Annual renewal of registration

Swiss-specific testing:
Some devices may require additional testing or documentation:
- Swiss market-specific performance claims
- Language-appropriate clinical evaluation
- Compliance with Swiss electrical safety standards

Post-market surveillance:

Vigilance reporting:
Manufacturers and Swiss ARs must report to Swissmedic:
- Serious incidents leading to death or serious injury
- Field safety corrective actions and recalls
- Trends in adverse events
- Reporting timelines similar to EU MDR

Post-Market Surveillance (PMS):
- Ongoing collection of safety and performance data
- Periodic Safety Update Reports (PSUR)
- Complaint handling and trend analysis
- Proactive risk management updates

Clinical trial requirements:

For conducting clinical investigations in Switzerland:
- Swissmedic clinical trial authorization required
- Ethics committee approval
- Good Clinical Practice (GCP) compliance
- Trial registration in Swiss clinical trial portal
- Regular safety reporting during trial
- Final clinical trial report submission

Swiss Notified Bodies:

Designated Notified Bodies:
Swissmedic designates Swiss Notified Bodies (also called Third-Party Organizations or TPOs in Switzerland) to perform conformity assessments:
- ISO 13485 audits
- Technical file reviews
- Clinical evaluation assessments
- Issuing Swiss conformity certificates

Swiss Notified Bodies can:
- Issue Swiss certificates for Swiss market
- In some cases, issue EU certificates if designated by EU (complex post-MRA situation)

Timelines and approval process:

Registration timeline:
For devices with existing CE marking:
- Swiss AR designation: 1-2 weeks
- Database registration: 2-4 weeks
- Total: 1-2 months

For devices requiring Swiss conformity assessment:
- Documentation preparation: 3-6 months
- Notified Body review: 2-6 months
- Swissmedic registration: 1 month
- Total: 6-13 months

Comparison to EU process:

Similarities:
- Risk-based classification system
- Conformity assessment with Notified Bodies
- ISO 13485 quality management requirements
- Clinical evaluation and post-market surveillance
- Vigilance and incident reporting

Differences:
- Separate registration database and Swiss AR required
- Multi-language labeling (German, French, Italian)
- MRA status uncertain for MDR/IVDR devices
- Smaller market size but high regulatory expectations
- Some Swiss-specific legal requirements

Best practices for Swiss market entry:

Leverage CE marking:
- Obtain CE marking under EU MDR/IVDR first
- Use CE marking as basis for Swiss registration
- Ensure clinical data and labeling support Swiss market

Engage Swiss AR early:
- Choose experienced Swiss AR with Swissmedic relationships
- Involve in regulatory strategy and planning
- Ensure adequate resources for post-market duties

Multi-language preparation:
- Prepare German, French, Italian labeling from start
- Ensure accurate translations by native speakers
- Consider Swiss-specific terminology preferences

Monitor MRA developments:
- Stay updated on Switzerland-EU MRA negotiations
- Adjust regulatory strategy based on MRA status
- Consider both Swiss and EU pathways depending on market priorities

Maintain Swiss compliance:
- Track Swiss regulatory updates separately from EU
- Comply with Swiss vigilance and PMS requirements
- Renew Swiss registrations annually
- Respond promptly to Swissmedic inquiries

Switzerland represents a small but high-value medical device market with rigorous regulatory standards closely aligned with the EU. Despite the MRA complexities, Swiss market access remains important for comprehensive European coverage, particularly for innovative, high-quality medical devices.